Portal de recerca
Un ensayo clínico abierto y aleatorizado sobre la profilaxis de la infección por teicoplanina en pacientes pediátricos con leucemia mieloide aguda
Dades bàsiques
- Protocol:
- 72779
- EURDRACT:
- 2020-000508-13
- NCT:
- Centre:
- HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
- Any inici:
- 2023
- Any de finalització:
Objectius del projecte
Objetivo Principal: Estudio de seguridad: Evaluar la seguridad de la profilaxis con teicoplanina tres veces por semana con un intervalo de dos a tres días en niños con LMA recién diagnosticada. Un paciente se considerará evaluable para la seguridad si experimenta una DLT durante un ciclo profiláctico con teicoplanina o, en caso de que no se produzca ninguna DLT, si la exposición a teicoplanina es de al menos 2 semanas consecutivas con al menos 5 dosis de teicoplanina o de al menos 3 semanas en total con al menos 6 de 9 dosis de teicoplanina, u 8 de 12 dosis en caso de 4 semanas, o 10 de 15 dosis en caso de 5 semanas. Fase aleatoria: Evaluar si la profilaxis con teicoplanina en niños con LMA recién diagnosticada disminuye la aparición de ISB probadas por cultivo con VGS durante el tratamiento. Objetivos Secundarios: Estudio de seguridad: Caracterizar los parámetros PK de teicoplanina en niños con LMA recién diagnosticada. Ensayo controlado aleatorio: Evaluar si la profilaxis con teicoplanina disminuye la aparición de cualquier ISB bacteriana probada por cultivo; evaluar el impacto de la teicoplanina en el número de ingresos en cuidados intensivos; la frecuencia de morbilidad y mortalidad relacionadas con la infección; evaluar si la teicoplanina afecta al tiempo de recuperación de los neutrófilos; el desarrollo de la resistencia bacteriana relacionada con la teicoplanina; la seguridad y los EA; estudiar si existe un efecto de confusión del uso de otros antibióticos (p. ej, evaluar los parámetros PK y construir un modelo PK poblacional; estudiar el efecto potencial de las covariables sobre el aclaramiento de teicoplanina; asociaciones entre los niveles séricos de teicoplanina y la aparición de infecciones bacterianas (VGS) probadas por cultivo. Describir el CIR, la EFS y la OS.
Documents
- No hi ha documents
Grups d'Investigació
Finançadors - Promotors
Resultats de l'Assaig Clínic
[Translated article] Knowledge of biological therapy in patients with immune-mediated diseases. BIOINFO study.
Segui-Solanes, Carlos; (...); Borras-Blasco, Joaquin
Article. 10.1016/j.farma.2024.08.002. 2024
[Translated article] New challenges in advanced therapies.
Megías-Vericat JE; (...); Poveda Andrés JL
Article. 10.1016/j.farma.2024.05.001. 2024
[Translated article] Pharmacokinetic-guided switching from standard half-life factor VIII to extended half-life pegylated factor VIII in haemophilia A therapy in clinical practice.
Chovi-Trull, Maria; (...); Andres, Jose Luis Poveda
Article. 10.1016/j.farma.2024.12.007. 2025
A Randomized Comparison of Liposomal Daunorubicin/Daunorubicin Combined with Low-Dose Cytarabine and Etoposide or High-Dose Cytarabine and Fludarabine in Induction Treatment of Pediatric AML Using MRD- Based Risk Stratification in the NOPHO-DBH AML 2012 Protocol
De Moerloose, Barbara; (...); Abrahamsson, Jonas
Meeting Abstract. 10.1182/blood-2023-187251. 2023
Accurate donor and recipient selection and a short time to transplant offer excellent outcomes in upfront hematopoietic stem cell transplantation from matched unrelated donors for pediatric severe aplastic anemia and refractory cytopenia of childhood. A study of the Spanish Pediatric Group for Hematopoietic Cell Transplantation and Cell Therapy (GETH-TC).
Uria-Oficialdegui, M Luz; (...); Diaz-de-Heredia, Cristina
Letter. 10.1038/s41409-024-02406-z. 2024
ANALYSIS OF TREATMENT AND OUTCOME OF RELAPSED ACUTE LYMPHOBLASTIC LEUKEMIA ACCORDING TO IMMUNOPHENOTYPE IN SPAIN
Ramos Elbal, Eduardo; (...); Fuster, Jose Luis
Meeting Abstract. 2023
Atypical B-Cell Acute Lymphoblastic Leukemia with iAMP21 in the Context of Constitutional Ring Chromosome 21: A Case Report and Review of the Genetic Insights.
Gil, Jose Vicente; (...); Llop, Marta
Article. 10.3390/ijms26010357. 2025
Benefits of physical activity self-monitoring in patients with haemophilia: a prospective study with one-year follow-up.
Pérez-Alenda S; (...); Núñez-Cortés R
Article. 10.1111/hae.14988. 2024
Cefiderocol pharmacokinetics in critically ill patients undergoing ECMO support.
Marín-Cerezuela M; (...); Ramirez P
Letter. 10.1186/s13054-024-05126-4. 2024
CLINICAL EXPERIENCE IN THE USE OF MESENCHYMAL STROMAL CELLS IN PEDIATRIC GRAFT-VERSUS-HOST DISEASE: ON BEHALF OF THE SPANISH GROUP OF STEM CELL TRANSPLANTATION (GETH)
Echecopar Parente, Carlos; (...); Perez-Martinez, Antonio
Meeting Abstract. 2024
CMV REACTIVATIONS IN ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANT FROM HLA-MATCHED AND HAPLOIDENTICAL DONORS WITH POST-TRANSPLANT CYCLOPHOSPHAMIDE.
Article. 10.1016/j.jtct.2024.01.082. 2024
Comprehensive detection of CRLF2 alterations in acute lymphoblastic leukemia: a rapid and accurate novel approach.
Gil, Jose Vicente; (...); Barragan, Eva
Article. 10.3389/fmolb.2024.1362081. 2024
Correction to: Spanish registry of hemoglobinopathies and rare anemias (REHem- AR): demographics, complications, and management of patients with ß-thalassemia.
Bardón-Cancho EJ; (...); Cela E
Correction. 10.1007/s00277-024-05838-1. 2024
Cost-effectiveness and cost-utility analysis of haemate-P versus other von willebrand disease treatments in Spain.
Megias-Vericat, Juan E; (...); Yan, Songkai
Article. 10.1080/13696998.2025.2474886. 2025
Cytogenetic Assessment and Risk Stratification in Myelofibrosis with Optical Genome Mapping.
Diaz-Gonzalez, Alvaro; (...); Such, Esperanza
Article. 10.3390/cancers15113039. 2023
Cytomegalovirus DNAemia in hematological patients undergoing CD19-directed CAR-T cell therapy: should it be systematically monitored?
Solano de la Asuncion, Carlos; (...); Navarro, David
Letter. 10.1016/j.cmi.2023.05.010. 2023
Characterization of Pediatric Acute Myeloid Leukemia With t(7;12)(q36;p13)
Ostlund, Anders; (...); Palmqvist, Lars
Article. 10.1002/gcc.70003. 2024
Chip-AML22 Master Protocol: An Open-Label Clinical Trial in Newly Diagnosed Pediatric De Novo Acute Myeloid Leukemia (AML) Patients Including a Linked Phase II Trial with Quizartinib in FLT3-ITD/ NPM1wt Patients - a Study By the NOPHO-DB-SHIP Consortium
Kaspers, Gertjan J. L.; (...); Pronk, Cornelis Jan
Meeting Abstract. 10.1182/blood-2023-181792. 2023
Development and testing of a mobile app for systematic collection of patient-reported outcomes (PROs) in patients with hemophilia.
Megias-Vericat, J E; (...); Poveda Andres, J L
Letter. 10.1016/j.thromres.2024.109122. 2024
Disseminated toxoplasma infection after hematopoietic stem cell transplantation with myositis and encephalitis.
Asensi Cantó P; (...); Guerreiro M
Article. 10.1111/tid.14067. 2023
Distal Access Catheter Improves Balloon Guide and Stent Retriever Thrombectomy Outcomes in Nonagenarians.
Puig, Josep; (...); Blasco, Jordi
Article. 10.1111/jon.70012. 2025
ECLIM-SEHOP: how to develop a platform to conduct academic trials for childhood cancer.
Juan-Ribelles A; (...); Fernández-Teijeiro A
Article. 10.1007/s12094-024-03445-0. 2024
Enhancing Cytogenetic Diagnostics: Incorporating Optical Genome Mapping in the Laboratory Routine
Diaz-Gonzalez, Alvaro; (...); Such, Esperanza
Meeting Abstract. 10.1182/blood-2023-180691. 2023
Four cases of unexpected severe community-acquired pneumonia aetiology: Group A Streptococcus pyogenes disruption
Talavera, Monica; (...); Ramirez, Paula
Letter. 10.1016/j.medin.2023.04.013. 2023
Four cases of unexpected severe community-acquired pneumonia aetiology: Group A Streptococcus pyogenes disruption.
Talavera, Monica; (...); Ramirez, Paula
Case Reports. 10.1016/j.medine.2023.05.004. 2023
Genetic Characterization of Extensively Drug-Resistant Shigella sonnei Infections, Spain, 2021-2022
Jacqueline, Camille; (...); Herrera-Leon, Silvia
Article. 10.3201/eid2911.221746. 2023
Haploidentical versus Cord Blood transplantation in pediatric AML. A retrospective outcome analysis on behalf of the pediatric subcommittee of GETH (Grupo Español de Trasplante Hematopoyético).
Sisinni L; (...); de Heredia CD
Article. 10.1016/j.jtct.2024.07.013. 2024
Haploidentical vs. HLA-matched donor hematopoietic stem-cell transplantation for pediatric patients with acute lymphoblastic leukemia in second remission: A collaborative retrospective study of the Spanish Group for Bone Marrow Transplantation in Children (GETMON/GETH) and the Spanish Childhood Relapsed ALL Board (ReALLNet).
Moreno, Celia; (...); Fuster, Jose Luis
Article. 10.3389/fped.2023.1140637. 2023
Hematopoietic stem cell transplantation in children with chronic granulomatous disease: the Spanish experience.
Alonso García L; (...); Diaz de Heredia Rubio C
Article. 10.3389/fimmu.2024.1307932. 2024
Incidence and Risk Factors for Development of Cardiac Toxicity in Adult Patients with Newly Diagnosed Acute Myeloid Leukemia
Boluda, Blanca; (...); Montesinos, Pau
Article. 10.3390/cancers15082267. 2023
Management of Hyperleukocytosis in Pediatric Acute Myeloid Leukemia Using Immediate Chemotherapy without Leukapheresis, in Protocol NOPHO-DBH AML-2012
Zeller, Bernward; (...); Abrahamsson, Jonas
Meeting Abstract. 10.1182/blood-2023-184921. 2023
Management of hyperleukocytosis in pediatric acute myeloid leukemia using immediate chemotherapy without leukapheresis: results from the NOPHO-DBH AML 2012 Protocol.
Zeller B; (...); Abrahamsson J
Article. 10.3324/haematol.2024.285285. 2024
Measurable Residual Disease and Fusion Partner Independently Predict Survival and Relapse Risk in Childhood KMT2A-Rearranged Acute Myeloid Leukemia: A Study by the International Berlin-Frankfurt-Münster Study Group.
van Weelderen, Romy E; (...); Kaspers GJL
Article. 10.1200/JCO.22.02120. 2023
Mental, emotional and social dimensions of quality of life and their relationship with physical and functional status in adults with haemophilia.
Rodríguez MA; (...); Chimeno-Hernández A
Article. 10.1016/j.thromres.2024.109181. 2024
Mitoxantrone Versus Liposomal Daunorubicin in Induction of Pediatric AML With Risk Stratification Based on Flow Cytometry Measurement of Residual Disease.
Tierens, Anne; (...); Abrahamsson, Jonas
Article. 10.1200/JCO.23.01841. 2024
New Cases and Mutations in SEC23B Gene Causing Congenital Dyserythropoietic Anemia Type II.
Musri, Melina Mara; (...); Sanchez, Mayka
Article. 10.3390/ijms24129935. 2023
New challenges of advanced therapies.
Megías-Vericat JE; (...); Poveda Andrés JL
Article. 10.1016/j.farma.2023.11.008. 2024
Optimized Cytogenetic Risk-Group Stratification of KMT2A-Rearranged Pediatric Acute Myeloid Leukemia.
van Weelderen, Romy E.; (...); Kaspers, Gertjan J. L.
Article. 10.1182/bloodadvances.2023011771. 2024
Pharmacogenetics in Response to Biological Agents in Inflammatory Bowel Disease: A Systematic Review.
Ballesta-Lopez, Octavio; (...); Poveda-Andres, Jose Luis
Article. 10.3390/ijms26041760. 2025
POST-TRANSPLANT RELAPSE IN PEDIATRIC ACUTE LYMPHOBLASTIC LEUKEMIA IN THE ERA OF CAR-T CELL THERAPY. A MULTICENTER ANALYSIS OF GRUPO ESPANOL DE TRASPLANTE HEMATOPOYETICO Y TERAPIA CELULAR (GETHTC) PEDIATRIC COMMITTEE
Vicent, Marta Gonzalez; (...); de Heredia, Cristina Diaz
Meeting Abstract. https://doi.org/10.1016/j.jcyt.2024.11.016. 2024
Post-transplant relapse in pediatric acute lymphoblastic leukemia in the era of CAR-T cell therapy. A multicenter analysis of Grupo Espanol de Trasplante Hematopoyetico y Terapia Celular (GETH-TC) Pediatric Committee.
Gonzalez Vicent, M; (...); Diaz de Heredia, C
Article. 10.1016/j.jcyt.2024.11.016. 2024
Spanish registry of hemoglobinopathies and rare anemias (REHem-AR): demographics, complications, and management of patients with ß-thalassemia.
Bardón-Cancho EJ; (...); Cela E
Article. 10.1007/s00277-024-05694-z. 2024
Switching from immediate- to extended-release cysteamine in patients with nephropathic cystinosis: from clinical trials to clinical practice.
Ariceta G; (...); Vara J
Article. 10.1093/ckj/sfae049. 2024
Toxic-metabolic encephalopathy induced by metronidazole and disulfiram: classics never die.
Chovi-Trull, Maria; (...); Poveda-Andres, Jose Luis
Article. 10.1136/ejhpharm-2024-004184. 2024
Treosulfan-Based Conditioning Regimen In Pediatric Hematopoietic Stem Cell Transplantation: A Retrospective Analysis on Behalf of the Spanish Group for Hematopoietic Transplantation and Cellular Therapy (GETH-TC).
Galán V; (...); Pérez-Martínez A
Article. 10.1016/j.jtct.2023.08.016. 2023
UNRELATED DONOR TRANSPLANTATION OFFERS A REAL CURATIVE OPPORTUNITY FOR PATIENTS WITH TRANSFUSIONDEPENDENT THALASSAEMIA. EXPERIENCE OF THE SPANISH GROUP FOR BONE MARROW TRANSPLANTATION IN CHILDREN (GETH-TC)
Benitez Carabante, Maria Isabel; (...); de Heredia Rubio, Cristina Diaz
Meeting Abstract. 2024
UPFRONT MATCHED UNRELATED DONOR HEMATOPOIETIC STEM CELL TRANSPLANTATION FOR SEVERE IDIOPATHIC APLASTIC ANEMIA AND REFRACTORY CYTOPENIA OF CHILDHOOD IN PEDIATRIC PATIENTS. SPANISH EXPERIENCE
Uria-Oficialdegui, M. Luz; (...); Diaz-de-Heredia, Crsitina
Meeting Abstract. 2024
Use of Eculizumab in Pediatric Patients with High-Risk Transplantation-Associated Thrombotic Microangiopathy: Outcomes and Risk Factors Associated with Response and Survival. A Retrospective Study on Behalf of the Spanish Group for Hematopoietic Transplantation and Cellular Therapy (GETH-TC).
Benítez Carabante MI; (...); Diaz-de-Heredia C
Article. 10.1016/j.jtct.2024.03.019. 2024